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PREA, PK And Safety PASS Study Of IV Pantoprazole In Pediatric Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02401035
Recruitment Status : Terminated (Study was terminated early due to the infeasibility of enrolling the required number of participants per protocol in the 1 <2 years of age cohort.)
First Posted : March 27, 2015
Last Update Posted : April 11, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
The purpose of this study is to characterize the pharmacokinetics (PK) and safety of intravenous (IV) pantoprazole in patients 1 to 16 years old who are candidates for acid suppression therapy.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Drug: IV pantoprazole Phase 4

Detailed Description:

In hospitalized pediatric subjects, age 1 to 16 years who in the judgment of the investigator are candidates for acid suppression therapy, the following are the objectives of this trial:

Primary Objectives To characterize the PK of single and multiple IV doses of pantoprazole in pediatric subjects aged 1 to less than 2 years old.

To characterize the PK of single and multiple IV doses of pantoprazole in pediatric subjects aged 2 to 16 years old.

Secondary Objectives To determine the safety, tolerability, and PK of single and multiple IV doses of pantoprazole in each of the independent age cohorts.

To assess the CYP2C19 genotype in pediatric subjects receiving IV pantoprazole, to determine the presence of the gene for the major enzyme responsible for metabolism of pantoprazole.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE PHARMACOKINETICS OF SINGLE AND MULTIPLE INTRAVENOUS DOSES OF PANTOPRAZOLE IN TWO AGE COHORTS OF HOSPITALIZED PEDIATRIC SUBJECTS 1 TO 16 YEARS OF AGE WHO ARE CANDIDATES FOR ACID SUPPRESSION THERAPY
Actual Study Start Date : May 9, 2017
Actual Primary Completion Date : February 4, 2023
Actual Study Completion Date : February 4, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: IV pantoprazole
Patients will receive 10 mg, 20 mg, or 40 mg IV pantoprazole determined by weight.
 Drug: IV pantoprazole
Patients will receive 10 mg, 20 mg, or 40 mg IV pantoprazole determined by weight


Outcome Measures
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Primary Outcome Measures :
  1. Volume of distribution of IV pantoprazole [ Time Frame: Day 1 ]
    Pharmacokinetic parameters will be summarized descriptively

  2. Clearance of IV pantoprazole [ Time Frame: Day 1 ]
    Pharmacokinetic parameters will be summarized descriptively

  3. Volume of distribution of IV pantoprazole [ Time Frame: Day 2 ]
    Pharmacokinetic parameters will be summarized descriptively

  4. Clearance of IV pantoprazole [ Time Frame: Day 2 ]
    Pharmacokinetic parameters will be summarized descriptively


Secondary Outcome Measures :
  1. CYP2C19 genotyping [ Time Frame: Day 1 ]
    CYP2C19 genotyping will be summarized descriptively

  2. Maximum Plasma Concentration [ Time Frame: Day 1 ]
    Pharmacokinetic parameters will be summarized descriptively

  3. Maximum Plasma Concentration [ Time Frame: Day 2 ]
    Pharmacokinetic parameters will be summarized descriptively

  4. Area under plasma concentration-time profile from 0 to 24 hours [ Time Frame: Day 1 ]
    Pharmacokinetic parameters will be summarized descriptively

  5. Area under plasma concentration-time profile from 0 to 24 hours [ Time Frame: Day 2 ]
    Pharmacokinetic parameters will be summarized descriptively

  6. Area under plasma concentration-time profile from time 0 extrapolated to infinite time [ Time Frame: Day 1 ]
    Pharmacokinetic parameters will be summarized descriptively

  7. Area under plasma concentration-time profile from time 0 extrapolated to infinite time [ Time Frame: Day 2 ]
    Pharmacokinetic parameters will be summarized descriptively

  8. Terminal half-life [ Time Frame: Day 1 ]
    Pharmacokinetic parameters will be summarized descriptively

  9. Terminal half-life [ Time Frame: Day 2 ]
    Pharmacokinetic parameters will be summarized descriptively


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects aged 1 to 16 years who in the judgment of the investigator are candidates for gastric acid suppression therapy (ie, those with a presumptive diagnosis of GERD, a clinical diagnosis of suspected GERD, symptomatic GERD, or endoscopically proven GERD) and whom the investigator judges would need to receive IV PPI therapy for at least 4 days.
  • Body weight > 5th percentile for age.
  • Y-site or dedicated IV line for administration of pantoprazole sodium.
  • Expected survival for at least 30 days.
  • Fertile male and female subjects of childbearing potential at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. Female subjects of non-childbearing potential must be premenarchal, have undergone hysterectomy with bilateral oophorectomy, have medically confirmed ovarian failure, or achieved post-menopausal status.

Exclusion Criteria:

  • Participation in other studies involving investigational drug(s) or treatment with an investigational drug within 30 days or 5 half lives prior to study entry and/or during study participation.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  • Pregnant females; breastfeeding females; fertile male subjects, and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days after last dose of investigational product.
  • Serum CK levels >3x ULN.
  • Known history of HIV or clinical manifestations of AIDS.
  • Known hypersensitivity to PPIs or to any substituted benzimidazole or to any of the excipients.
  • History of treatment with any PPI within 2 days (48 hours) before investigational product dosing on Day 1.
  • Use of H2RAs, sucralfate, misoprostol, or prokinetic agents, and bismuth preparations within 1 day (24 hours) before investigational product dosing on Day 1.
  • Any disorder requiring chronic (every day) use of warfarin, carbamazepine, or phenytoin, methotrexate, atazanavir or nelfinavir, clopidogrel, and potent inhibitors and inducers of CYP2C19.
  • Chronic (daily) use of glucocorticoids. Steroid inhalers and topical steroids may be used.
  • Active malignancy of any type, or history of a malignancy (Subject with a history of malignancies that have been surgically removed or eradicated by irradiation or chemotherapy and who have no evidence of recurrence for at least 5 years before Screening are acceptable).
  • ALT or BUN >2.0 ULN or estimated creatinine >1.5 X ULN for age or any other laboratory abnormality considered by the Investigator to be clinically significant within 14 days before Screening.
  • In the Investigator's opinion, a chronic condition (eg, diabetes, epilepsy), which is either not stable or well controlled and may interfere with the conduct of the study.
  • History of sensitivity to heparin or heparin induced thrombocytopenia.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02401035


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02401035    
Other Study ID Numbers: B1791089
2014-002182-29 ( EudraCT Number )
B1791089 ( Other Identifier: Study Number )
GERD ( Other Identifier: Alias Study Number )
First Posted: March 27, 2015    Key Record Dates
Last Update Posted: April 11, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
candidate for acid suppression therapy
presumptive diagnosis of GERD
clinical diagnosis of suspected GERD
symptomatic GERD
endoscopically proven GERD
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action